NCT07021079

Brief Summary

Muscle deconditioning, characterized by a loss of muscle mass and strength, is a frequent consequence of prolonged lower limb unloading. Beyond muscle mass loss, reduced neural drive contributes significantly to strength decline, highlighting the need for interventions targeting neuromuscular function during immobilization. Focal muscle vibration (FMV) has shown promise in modulating neuromuscular excitability by activating muscle spindle afferents and inducing cortical adaptations. Chronic use of FMV has been associated with significant strength gains and improved neural command. This makes FMV an effective rehabilitation tool. Its simplicity and non-invasiveness further make it a practical countermeasure.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Jun 2025Aug 2027

First Submitted

Initial submission to the registry

March 10, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

June 16, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

November 26, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

March 10, 2025

Last Update Submit

November 21, 2025

Conditions

Vibration TherapyHealthy Volunteer StudyHypoactivity

Keywords

hypoactivityneuromuscular deconditionningVibration

Outcome Measures

Primary Outcomes (1)

  • Isometric force measurement

    Maximal isometric force (% decrease) in knee extension of the immobilized leg will be evaluated

    Day 1, 7, 14, 28, 33

Secondary Outcomes (13)

  • Maximum voluntary force measurement

    Day 1, 7, 14, 28, 33

  • Jumping performance measurement

    Day 1, 7, 14, 28, 33

  • Postural balance measurement

    Day 1, 7, 14, 28, 33

  • Neuromuscular fatigue measurement

    Day 1, 7, 14, 28, 33

  • Force-velocity-endurance measurement

    Day 1, 7, 14, 28, 33

  • +8 more secondary outcomes

Study Arms (2)

VIBRATION

ACTIVE COMPARATOR

Participants will benefit a local vibration countermeasure program for the knee extensor muscles.

Device: Focal muscle vibration

CONTROLE

SHAM COMPARATOR

the control group WILL not receive this countermeasure.

Device: NO Focal muscle vibration

Interventions

Focal muscle vibrationDEVICE

focal muscle vibration sessions, using small and portable vibrator devices.

VIBRATION
NO Focal muscle vibrationDEVICE

The control group will not receive any intervention.

CONTROLE

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women.
  • Aged 18 to 45 years.
  • Body Mass Index (BMI) between 20 and 25 kg/m².
  • Engaging in at least 1.5 hours per week of physical activity (e.g., brisk walking, running, swimming, cycling).
  • Provided informed consent after receiving detailed information about the study.
  • Affiliated with or beneficiaries of a social security system

You may not qualify if:

  • Chronic cardiovascular, neuromuscular, bone, metabolic, and/or inflammatory disorders.
  • Personal history and/or risk factors for thrombosis.
  • Use of antidepressant medications.
  • Use of neuroactive substances likely to alter corticospinal excitability (e.g., hypnotics, antiepileptics, psychotropics, muscle relaxants) during the study.
  • Recent bone or ligament trauma within the past 12 months.
  • Inability to perform the physical efforts required for the study.
  • Recent participation in a sporting competition or intense, unusual physical activity within the past month.
  • Corticosteroid treatment within the past 3 months.
  • Any skin lesions at the planned vibrator application site.
  • Simultaneous participation in another interventional medical study.
  • Pregnant or breastfeeding women.
  • Individuals unable to understand the purpose and conditions of the study or unable to provide informed consent.
  • Individuals deprived of liberty or under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • LEONARD FEASSON, PHD

    CENTRE HOSPITALIER UNIVERSITAIRE SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LEONARD FEASSON, PHD

CONTACT

(0)477120383leonard.feasson@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

June 13, 2025

Study Start

June 16, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

November 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)